(602 days)
A powder-free surgeons' glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove system was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy testing was carried out on the system as a whole, including both the under-glove together. Please note that the following drugs have extremely low permeation times: 3.0 minutes and Thiotepa: 67.0 minutes. Warning: Do not use with Carmustine or Thiotepa.
Gammex® Pl Plus Glove-in-Glove™ System tested for use with Chemotherapy Drugs is a sterile and disposable device. This glove system ismade of synthetic polyisoprene rubber. Gammex® Pl Plus Glove- in-Glove™ System Tested for Use with Chemotherapy Drugs is comprised of a single-use, sterile, white outer glove, which is a disposable, powder-free surgical glove made from synthetic polyisoprene and a single-use, sterile, green underglove which is a disposable, powder-free surgical glove made from syntheticpolyisoprene. The Gammex® Pl PlusGlove-in-Glove™ system Testedfor Use with Chemotherapy Drugs is comprised of the underglove being mechanically inserted into the outer glove prior to packing and sterilization. There is no adhesive present between the two gloves. This results in quick double gloving with only one donning event.
The provided text is a 510(k) Premarket Notification from the FDA regarding the "Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs." This document outlines the device's characteristics, its intended use, and the studies conducted to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document includes a table of non-clinical tests performed on the Gammex® PI Plus Glove-in-Glove™ System.
| Test Title | Purpose of Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D3767-03 | Dimensions | In accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves. | PASS |
| ASTM D3577-19 | Physical Properties | For tensile strength, ultimate elongation and stress at 500% elongation before and after accelerated aging for synthetic surgical gloves per ASTM D3577-19 : Standard Specification for Rubber Surgical Gloves. | PASS |
| ASTM D5151-19 | Freedom from holes | In accordance with ASTM D3577-19: Standard Specification for Rubber Surgical Gloves with AQL requirements of 1.5. | PASS |
| ASTM D6124 | Powder-Free | Applicable acceptance criteria for powder free ≤ 2mg per glove per ASTM D3577-19: Standard Specification for Rubber Surgical Gloves. | PASS |
| ANSI/AAMI/ISO 11137-1:2006 | Sterility | Requirement of 10-6 SAL per ISO 11137-1: Sterilization for health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. | PASS |
| ASTM D6978-05(2019) | Chemotherapy Drug Permeation Test | In accordance with ASTM D6978-05(2019): Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Note: Carmustine (35.0 min) and Thiotepa (67.0 min) have extremely low permeation times, implying these are specific exceptions within the criteria or require special consideration/warnings. | PASS |
| ISO 10993-5 (Outer and Underglove) | ISO in vitro Cytotoxicity Study (Undiluted, 1:2, 1:4, 1:8, 1:16, 1:32, 1:64 dilutions) | Acceptance criteria in accordance with ISO 10993-5: Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity, 2009. (Specifically, for the outer glove: non-cytotoxic at 1:4, 1:8, 1:16, 1:32, and 1:64 dilutions. For the underglove: non-cytotoxic at 1:16, 1:32, and 1:64 dilutions). Intermediate dilutions for both gloves showed varying levels of cytotoxicity. | FAIL (at certain dilutions for both gloves, e.g., undiluted and 1:2 for outer; undiluted, 1:2, 1:4, 1:8 for under) |
| ISO 10993-10:2010 | ISO Skin Irritation Study | Passes Primary Skin Irritation test per ISO 10993-10, Biological Evaluation of medical devices, Part 10: Test for irritation and skin sensitization. Not an irritant under study conditions. | PASS |
| ISO 10993-10:2010 | ISO Maximization Sensitization Study | Passes Dermal Sensitization test per ISO 10993-10, Biological Evaluation of medical devices, Part 10: Test for irritation and skin sensitization. Not a sensitizer under study conditions. | PASS |
| ISO 10993-11:2017 | ISO Acute Systemic Toxicity Study | Passes Acute Systemic Toxicity Test per ISO 10993-11, Biological Evaluation of medical devices, Part 11: Test for systemic toxicity. No mortality or evidence of acute systemic toxicity under study conditions. | PASS |
Chemotherapy Drug Permeation Times (Detailed)
| Test Chemotherapy Drug & Concentration | Average Breakthrough Detection Time (Minutes) |
|---|---|
| Bleomycin - 15.0 mg/ml | >240 |
| Busulfan - 6.0 mg/ml | >240 |
| Carboplatin - 10 mg/ml | >240 |
| Carmustine - 3.3 mg/ml | 35.0 |
| Cisplatin - 1.0 mg/ml | >240 |
| Cyclophosphamide - 20.0 mg/ml | >240 |
| Cytarabine HCl - 100.0 mg/ml | >240 |
| Dacarbazine - 10.0 mg/ml | >240 |
| Daunorubicin HCl - 5.0 mg/ml | >240 |
| Docetaxel - 10.0 mg/ml | >240 |
| Doxorubicin HCl 2.0 mg/ml | >240 |
| Epirubicin - 2.0 mg/ml | >240 |
| Etoposide - 20.0 mg/ml | >240 |
| Fludarabine - 25 mg/ml | >240 |
| Fluorouracil - 50.0 mg/ml | >240 |
| Gemcitabine - 38.0 mg/ml | >240 |
| Idarubicin - 1.0 mg/ml | >240 |
| Ifosfamide - 50.0 mg/ml | >240 |
| Irinotecan - 20.0 mg/ml | >240 |
| Mechlorethamine HCl - 1.0 mg/ml | >240 |
| Melphalan - 5.0 mg/ml | >240 |
| Methotrexate - 25.0 mg/ml | >240 |
| Mitomycin C - 0.5 mg/ml | >240 |
| Mitoxantrone - 2.0 mg/ml | >240 |
| Oxaliplatin - 2.0 mg/ml | >240 |
| Paclitaxel - 6.0 mg/ml | >240 |
| Rituximab - 10.0 mg/ml | >240 |
| Thiotepa - 10.0 mg/ml | 67.0 |
| Vincristine Sulfate - 1.0 mg/ml | >240 |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify sample sizes for individual tests like dimensions, physical properties, freedom from holes, powder-free, sterility, or biocompatibility studies. The general phrasing "Meets ASTM D..." or "Passes..." suggests that the sample sizes typically required by these standards were used.
For the Chemotherapy Drug Permeation Test (ASTM D6978-05), while the results for each drug are provided (Average Breakthrough Detection Time), the document does not specify the number of samples (e.g., gloves or glove specimens) tested for each drug.
The data provenance is prospective in the sense that these are tests conducted specifically for this 510(k) submission to demonstrate the device's performance against established standards. There is no mention of country of origin for the data; it is assumed to be from a testing facility compliant with the mentioned standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The "ground truth" for these tests is defined by the objective measurement methods and acceptance criteria specified in the referenced ASTM, ANSI, and ISO standards. These standards themselves are developed by expert consensus, but specific independent expert adjudication for this particular test set is not mentioned or typically required for this type of device and testing.
4. Adjudication Method for the Test Set:
An explicit adjudication method (like 2+1 or 3+1) is not applicable or mentioned for the non-clinical tests described. The tests are objective measurements against predefined criteria outlined in the consensus standards. The "Pass/Fail" results are determined directly by comparing the test outcomes to these established thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a MRMC comparative effectiveness study was not done. The document explicitly states: "A clinical study was not conducted on the subject device." This type of study focuses on human reader performance, often with or without AI assistance, which is not relevant to the physical and chemical resistance properties of a surgical glove.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:
No, a standalone algorithm-only performance study was not done. This device is a physical medical device (surgical glove), not an algorithm or AI software. Therefore, studies evaluating algorithm performance are not relevant.
7. The Type of Ground Truth Used:
The ground truth used for the non-clinical tests is based on consensus standards and laboratory measurements.
- For physical properties, dimensions, freedom from holes, powder residue, and sterility: The ground truth is objective measurement against the specified ASTM and ISO standards' criteria.
- For chemotherapy drug permeation: The ground truth is the measured breakthrough time determined by the ASTM D6978-05 standard.
- For biocompatibility (skin irritation, sensitization, acute systemic toxicity, cytotoxicity): The ground truth is the biological response observed in validated in vitro and in vivo models according to the ISO 10993 series of standards.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical product (surgical glove) and does not involve AI or machine learning algorithms that would require a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).